ECHA

By the second REACH registration of 31 May, 3 215 companies submitted 9 084 registration dossiers for 2 923 substances to ECHA.

"We are one step closer to having a database of all the main chemicals  in Europe," says Kevin Pollard.

The number of dossiers and substances submitted was very close to ECHA's estimations, which were based on the information provided voluntarily by lead registrants of the substance information exchange forums (SIEFs) and on surveys carried out with industry organisations. "We received the expected number of registration dossiers. At the substance level, we did not receive registrations for all of those substances that industry had informed us about during the surveys, but this was partly compensated by submissions for other substances, of which industry had not given us a prior indication. Overall, the number of substances registered was close to our expectations. Some concerns were raised about those substances, which had been intended to be registered by industry but were not, but so far there has been no sign from the market that any essential substances would have ‘disappeared'. We will keep our ears open during the summer, but according to the first reactions from industry the differences between the intentions and the reality are due to shifts in the market and are not a concern."

ECHA will contact those lead registrants who originally intended to register substances for the deadline but after all did not, and ask for their reasons. "It is of course voluntary for leads to share this information. The main source of feedback for us is the downstream users and different industry sectors and whether they express their concern for a key substance no longer being on the market," Mr Pollard says.

Support provided to companies

The Agency started to provide support to REACH 2013 registrants right after the first deadline in 2010. It has held three stakeholders' days, two lead registrant workshops, broadcast a series of webinars and offered IT trainings.

In the last weeks before the deadline, ECHA helped 510 companies having technical difficulties with their submission by proactively calling them and sorting out the problems. In addition, a few companies experiencing problems in SIEF management were helped.

"The main issues close to the deadline were passing the business rules step in REACH-IT and problems with file format. The ‘business rules' is an automated check that confirms whether the information in the dossier is consistent. For example, if a company making an initial submission creates the dossier as an update, the system won't let it be processed. The file format has to do with making sure that the dossier is the right kind of IUCLID dossier," Mr Pollard explains.

The ECHA Helpdesk dealt with 425 questions related to REACH 2013 registrations in May. Of these, 62% had to do with REACH-IT blocked accounts.

In addition, ECHA has updated and created new IT tools, revamped the Helpdesk contact forms, and published new and updated guidance documents, fact sheets, practical guides and illustrative examples.

Focus on quality

At this stage, it is too early to say whether the quality of dossiers has improved for this second deadline. "We will know more about quality of data once the dossiers are passed on to evaluation. We have taken actions in the past years to help companies prepare good quality dossiers, the most recent development being the Dossier Quality Assistant tool launched in February," Kevin Pollard points out.

ECHA has gained experience on dossier quality since 2010 and is now well prepared to tackle potential quality issues in the REACH 2013 dossiers. It will carry out database screening on the registered dossiers in order to examine quality, including further targeted screenings on intermediate use and substance identity.

ECHA will also continue to verify the SME status of those registrants claiming to be small, medium or micro companies.

REACH 2018

The last REACH registration deadline is on 31 May 2018 for phase-in substances manufactured in the European Union or imported in quantities of one tonne or more per year.

The last deadline is expected to be quite different from the two previous ones, with many more registrations prepared by small SIEFs or individual registrants, and concerning many more SMEs than before.

"This final deadline is expected to generate the highest number of registrations and there will also probably be far more inexperienced registrants. In this respect, the advice provided by the national REACH and CLP helpdesks becomes even more important as they will be the first line helpers for companies in their own languages," says Kevin Pollard.

The major challenge related to the last registration deadline will be reaching out to the smaller companies. To this aim, ECHA intends to establish a roadmap for 2015-2018, in collaboration with stakeholders to adapt and streamline procedures, IT tools and support to the registrants.

"Although the European Commission's REACH Review concluded that the implementation of REACH is proving to be a success, it also recommended that work be done to see if sharing of data can be improved. Dialogue will be needed to gather feedback from industry in an attempt to identify potential changes either to the data sharing process or to the pre-SIEF in REACH-IT. At the same time, consideration will be given to SMEs and whether there is a possibility to simplify the process for them," Mr Pollard highlights.

Another area of improvement is the technical dossier submission system. "Our aim is to upgrade the system to make the submission of member dossiers technically more straightforward," he concludes.

Director of Registration, Ms Christel Musset, and Executive Director Geert Dancet presented the results of the second registration deadline at a press conference in Brussels.

Further information:

• REACH 2013 results
• Information for registrants 
• Information for downstream users 
• ECHA receives updates for intermediate dossiers and announces further follow-up actions, News alert 14 February 2013 
• SME verification 

Next steps for registrants   The most important advice to registrants is: Follow up on your registration. Your dossier is your responsibility. You need to keep it up-to-date.   Right after submission:   If your dossier fails the technical completeness check (TCC) undertaken by ECHA, you will receive a letter in your REACH-IT account. The letter will include instructions on how to proceed, including a timeframe to resubmit your dossier (usually four months). Should your registration fail the TCC for a second time, it will be rejected. If you have any doubt about how to address the result of the TCC, contact the ECHA Helpdesk. Remember that your registration will only be considered complete, if the registration fee is paid within the deadline indicated in your invoice. Make sure that your accounting department has received the relevant invoices and has made arrangements to pay them on time. Non-payment of the fee will result in the rejection of the registration. Once you have completed your registration:   Registration is not the end, it's only the beginning. If you were in a rush to prepare your dossiers, have a look at our advice and tools for maximising quality of information and proactively review and correct any deficiencies you are aware of. ECHA will be carrying out targeted IT screening on the dossiers and if deficiencies are found, the dossier may be prioritised for compliance check under evaluation. Update your dossier as soon as possible when you receive new data and reasoning. ECHA's quality advice and tools Dossier Quality Assistant Webinars Evaluation reports Chemical safety report illustrative examples

Text by Hanna-Kaisa Torkkeli